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IRCT20090117001556N119 IRCT 2019-03-17 Tehran University of Medical Sciences Evaluation of the efficacy of gemfibrozil as an adjunct therapy in improving the symptoms of major depressive disorder Evaluation of the efficacy of gemfibrozil as an adjunct therapy in improving the symptoms of major depressive disorder; A double- blind, placebo-controlled trial 2019-04-05 anticipated 40 Complete https://irct.ir/trial/38328 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random permuted block, Blinding description: The participants, clinicians and outcome raters will be blind regarding grouping. 3 Major Depressive Disorder. Intervention 1: Intervention group: tablet sertralin 100 mg/day plus Capsule gemfibrozil 300 mg per day as intervention group for 8 weeks. Intervention 2: Control group: tablet sertralin 100 mg/day plus Capsule placebo as control group for 8 weeks. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2021 to 2026 To whom: Academic researchers Conditions: by citing the resourse Where to obtain: Professor Shahin Akhondzadeh How to obtain: by E mail Comments:
public Prof. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street,
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Prof. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Presence of Major Depressive Disorder based on DSM-5 criteria Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 22 Age between 18 to 60 years 18 years 60 years Both Presence of psychosis Substanse use disorder except for nicotine and caffeine IQ lower than 70 Any other mental disorder Any significant neurologic or medical disease(advanced renal disease, CKD, hepatic disease, cardiovascular disease) history of cholelithiasis Receiving Warfarin Recieving Insulin Receiving statins Receiving niacin F32.2 Major depressive disorder, single episode, severe without psychotic features Treatment - Drugs Placebo Intervention group: tablet sertralin 100 mg/day plus Capsule gemfibrozil 300 mg per day as intervention group for 8 weeks Control group: tablet sertralin 100 mg/day plus Capsule placebo as control group for 8 weeks Severity of depression. Timepoint: Baseline and weeks 2,4 and 8. Method of measurement: by Hamiltion Depression Rating Scale 17-Item. Tehran University of Medical Sciences Approved 2019-03-08 Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz Blv Tehran Tehran Iran (Islamic Republic of)